Left atrial appendage closure device

A left atrial appendage closure device may include an expandable framework having a plurality of struts joined at a proximal and distal hub. When the framework is fully constrained in a first position, a first segment of struts extends distally from the distal hub parallel to a central longitudinal axis to a first bend and a second segment of struts extends from the first bend proximally. A first amount of the framework is unconstrained in a second position, where the first segment extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment extends from the first bend proximally and radially outward to a second bend, a third segment of struts extends from the second bend proximally and radially inward to a third bend, and a fourth segment of struts extends from the third bend proximally to within the delivery sheath.

Skip to: Description  ·  Claims  ·  References Cited  · Patent History  ·  Patent History
Description
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 17/857,513, filed Jul. 5, 2022, which claims the benefit of priority of U.S. Provisional Application No. 63/219,696 filed Jul. 8, 2021, the entire disclosure of which is hereby incorporated by reference.

TECHNICAL FIELD

The disclosure relates generally to medical devices and more particularly to medical devices that are adapted for use in percutaneous medical procedures including implantation into the left atrial appendage (LAA) of a heart.

BACKGROUND

The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart function, as the left atrium constricts and forces blood into the left ventricle, the left atrial appendage constricts and forces blood into the left atrium. The ability of the left atrial appendage to contract assists with improved filling of the left ventricle, thereby playing a role in maintaining cardiac output. However, in patients suffering from atrial fibrillation, the left atrial appendage may not properly contract or empty, causing stagnant blood to pool within its interior, which can lead to the undesirable formation of thrombi within the left atrial appendage.

Thrombi forming in the left atrial appendage may break loose from this area and enter the blood stream. Thrombi that migrate through the blood vessels may eventually plug a smaller vessel downstream and thereby contribute to stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation originate in the left atrial appendage. As a treatment, medical devices have been developed which are deployed to close off the left atrial appendage. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and introducers as well as alternative methods for manufacturing and using medical devices and introducers.

SUMMARY

In one example, a left atrial appendage closure device may comprise an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined together at a proximal hub and a distal hub. When the expandable framework is fully constrained in a first position by a delivery sheath, a first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to a first bend and a second segment of the plurality of struts extends from the first bend proximally. A first amount of the expandable framework is unconstrained by the delivery sheath in a second position. In the second position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend proximally and radially outward to a second bend, a third segment of the plurality of struts extends from the second bend proximally and radially inward to a third bend, and a fourth segment of the plurality of struts extends from the third bend proximally to within the delivery sheath.

In addition or alternatively to any example disclosed herein, in the second position the first segment and the second segment form an acute angle opening inwardly toward an interior of the expandable framework.

In addition or alternatively to any example disclosed herein, a second amount of the expandable framework greater than the first amount is unconstrained by the delivery sheath in a third position. In the third position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend radially outward generally perpendicular to the central longitudinal axis to the second bend, the third segment of the plurality of struts extends from the second bend proximally and radially inward to the third bend, and the fourth segment of the plurality of struts extends from the third bend proximally toward the proximal hub disposed within the delivery sheath.

In addition or alternatively to any example disclosed herein, in the third position the second segment and the third segment form an acute angle opening inwardly toward the central longitudinal axis.

In addition or alternatively to any example disclosed herein, in the third position the third segment and the fourth segment form an obtuse angle opening outwardly away from the central longitudinal axis.

In addition or alternatively to any example disclosed herein, a third amount of the expandable framework greater than the second amount is unconstrained by the delivery sheath in a fourth position. In the fourth position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend distally and radially outward to the second bend, the third segment of the plurality of struts extends from the second bend proximally and radially inward toward the third bend, and the fourth segment of the plurality of struts extends from the third bend proximally toward the proximal hub disposed within the delivery sheath.

In addition or alternatively to any example disclosed herein, in the fourth position the first segment and the second segment form an obtuse angle opening inwardly toward an interior of the expandable framework.

In addition or alternatively to any example disclosed herein, in the fourth position the second segment and the third segment form an acute angle opening inwardly toward the central longitudinal axis.

In addition or alternatively to any example disclosed herein, in the fourth position the third segment and the fourth segment form an obtuse angle opening outwardly away from the central longitudinal axis.

In addition or alternatively to any example disclosed herein, a fourth amount of the expandable framework greater than the third amount is unconstrained by the delivery sheath in a fifth position. In the fifth position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend distally and radially outward to the second bend, the third segment of the plurality of struts extends from the second bend proximally to the third bend, and the fourth segment of the plurality of struts extends from the third bend radially inward toward the proximal hub.

In addition or alternatively to any example disclosed herein, in the fifth position the first segment and the second segment form an obtuse angle opening inwardly.

In addition or alternatively to any example disclosed herein, in the fifth position the second segment and the third segment form an acute angle opening inwardly.

In addition or alternatively to any example disclosed herein, in the fifth position the third segment and the fourth segment form an angle of about 90 degrees or less opening inwardly.

In addition or alternatively to any example disclosed herein, the distal hub is disposed proximal of the first bend.

In addition or alternatively to any example disclosed herein, in the second position the distal hub is disposed distal of the second bend.

In addition or alternatively to any example disclosed herein, a left atrial appendage closure device may comprise an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined together at a proximal hub and a distal hub. As the expandable framework shifts from fully constrained to fully unconstrained, the expandable framework transitions sequentially through a plurality of positions. In a first position, a first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to a first bend and a second segment of the plurality of struts extends from the first bend proximally and generally parallel to the central longitudinal axis. In a second position, the second segment of the plurality of struts, if swept circumferentially around the central longitudinal axis, defines a generally conical shape tapering radially outward in a proximal direction from the first bend toward a second bend.

In addition or alternatively to any example disclosed herein, in the second position, the distal hub is disposed proximal of the first bend and the distal hub is disposed distal of the second bend.

In addition or alternatively to any example disclosed herein, in a third position, the second segment of the plurality of struts, if swept circumferentially around the central longitudinal axis, defines a generally planar shape oriented generally perpendicular to the central longitudinal axis.

In addition or alternatively to any example disclosed herein, in a fourth position, the second segment of the plurality of struts, if swept circumferentially around the central longitudinal axis, defines a generally conical shape tapering radially outward in a distal direction from the first bend toward the second bend.

In addition or alternatively to any example disclosed herein, a left atrial appendage closure device system may comprise a delivery sheath having a lumen extending therein, and a left atrial appendage closure device comprising an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined together at a proximal hub and a distal hub. When the expandable framework is disposed within the lumen of the delivery sheath in a first position, a first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to a first bend and a second segment of the plurality of struts extends from the first bend proximally. Relative axial translation between the delivery sheath and the expandable framework exposes some of the expandable framework in a second position. In the second position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend proximally and radially outward to a second bend, a third segment of the plurality of struts extends from the second bend proximally and radially inward to a third bend, and a fourth segment of the plurality of struts extends from the third bend proximally to within the delivery sheath. Relative axial translation between the delivery sheath and the expandable framework exposes more of the expandable framework in a third position than in the second position. In the third position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend radially outward generally perpendicular to the central longitudinal axis to the second bend, the third segment of the plurality of struts extends from the second bend proximally and radially inward to the third bend, and the fourth segment of the plurality of struts extends from the third bend proximally toward the proximal hub disposed within the delivery sheath. Relative axial translation between the delivery sheath and the expandable framework exposes more of the expandable framework in a fourth position than in the third position. In the fourth position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend distally and radially outward to the second bend, the third segment of the plurality of struts extends from the second bend proximally and radially inward toward the third bend, and the fourth segment of the plurality of struts extends from the third bend proximally toward the proximal hub disposed within the delivery sheath. Relative axial translation between the delivery sheath and the expandable framework exposes all of the expandable framework in a fifth position. In the fifth position the first segment of the plurality of struts extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment of the plurality of struts extends from the first bend distally and radially outward to the second bend, the third segment of the plurality of struts extends from the second bend proximally to the third bend, and the fourth segment of the plurality of struts extends from the third bend radially inward toward the proximal hub.

The above summary of some embodiments, aspects, and/or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description more particularly exemplify aspects of these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

FIGS. 1-2 are side views of a left atrial appendage closure device system;

FIG. 3 illustrates selected aspects of a left atrial appendage closure device;

FIG. 4 illustrates selected aspects of the left atrial appendage closure device of FIG. 3; and

FIGS. 5-9 are schematic partial cross-sectional views illustrating selected aspects related to deploying the left atrial appendage closure device of FIGS. 3-4.

While aspects of the disclosure are amenable to various modifications and alternative forms, examples are shown in the drawings and described herein. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the disclosure shall cover all modifications, equivalents, and alternatives falling within the spirit and scope thereof.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the present disclosure. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate exemplary aspects of the disclosure. However, in the interest of clarity and ease of understanding, while every feature and/or element may not be shown in each drawing, the feature(s) and/or element(s) may be understood to be present regardless, unless otherwise specified.

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (e.g., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges, and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. It is to be noted that in order to facilitate understanding, certain features of the disclosure may be described in the singular, even though those features may be plural or recurring within the disclosed embodiment(s). Each instance of the features may include and/or be encompassed by the singular disclosure(s), unless expressly stated to the contrary. For simplicity and clarity purposes, all elements of the present disclosure are not necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may apply equally to any and/or all of the components for which there are more than one, unless explicitly stated to the contrary. Additionally, not all instances of some elements or features may be shown in each figure for clarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”, variants thereof, and the like, may be generally considered with respect to the positioning, direction, and/or operation of various elements relative to a user/operator/manipulator of the device, wherein “proximal” and “retract” indicate or refer to closer to or toward the user and “distal” and “advance” indicate or refer to farther from or away from the user. In some instances, the terms “proximal” and “distal” may be arbitrarily assigned in an effort to facilitate understanding of the disclosure, and such instances will be readily apparent to the skilled artisan. Other relative terms, such as “upstream”, “downstream”, “inflow”, and “outflow” refer to a direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within a device. Still other relative terms, such as “axial”, “circumferential”, “longitudinal”, “lateral”, “radial”, etc. and/or variants thereof generally refer to direction and/or orientation relative to a central longitudinal axis of the disclosed structure or device.

The term “extent” may be understood to mean the greatest measurement of a stated or identified dimension, unless the extent or dimension in question is preceded by or identified as a “minimum”, which may be understood to mean the smallest measurement of the stated or identified dimension. For example, “outer extent” may be understood to mean an outer dimension, “radial extent” may be understood to mean a radial dimension, “longitudinal extent” may be understood to mean a longitudinal dimension, etc. Each instance of an “extent” may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an “extent” may be considered the greatest possible dimension measured according to the intended usage, while a “minimum extent” may be considered the smallest possible dimension measured according to the intended usage. In some instances, an “extent” may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently—such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

The terms “monolithic” and “unitary” shall generally refer to an element or elements made from or consisting of a single structure or base unit/element. A monolithic and/or unitary element shall exclude structure and/or features made by assembling or otherwise joining multiple discrete structures or elements together.

It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to effect the particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless contemplated as being combinable or arrangeable with each other to form other additional embodiments or to complement and/or enrich the described embodiment(s), as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and/or claims to name and/or differentiate between various described and/or claimed features. It is to be understood that the numerical nomenclature is not intended to be limiting and is exemplary only. In some embodiments, alterations of and deviations from previously used numerical nomenclature may be made in the interest of brevity and clarity. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc. or may be omitted entirely, and/or a different feature may be referred to as the “first” element. The meaning and/or designation in each instance will be apparent to the skilled practitioner.

The left atrial appendage may be attached to and in fluid communication with a left atrium of a patient's heart. In some patients, the left atrial appendage may have a complex geometry and/or irregular surface area. Those of skill in the art will also recognize that the medical devices and methods disclosed herein may be adapted for various sizes and shapes of the left atrial appendage, as necessary. The left atrial appendage may include a generally longitudinal axis arranged along a depth of a main body of the left atrial appendage. The main body may include a wall and an ostium forming a proximal mouth. In some embodiments, a lateral extent of the ostium and/or the wall may be smaller or less than a depth of the main body along the longitudinal axis, or a depth of the main body may be greater than a lateral extent of the ostium and/or the wall. In some embodiments, the left atrial appendage may include a tail-like element associated with a distal portion of the main body, which element may protrude radially or laterally away from the main body.

The following figures illustrate selected components and/or arrangements of a left atrial appendage closure device, a left atrial appendage closure device system, and/or methods of using the left atrial appendage closure device and/or the left atrial appendage closure device system. It should be noted that in any given figure, some features may not be shown, or may be shown schematically, for simplicity. Additional details regarding some of the components of the implant and/or the system may be illustrated in other figures in greater detail. While discussed in the context of occluding the left atrial appendage, the left atrial appendage closure device and/or the left atrial appendage closure device system may also be used for other interventions and/or percutaneous medical procedures within a patient. Similarly, the devices and methods described herein with respect to percutaneous deployment may be used in other types of surgical procedures, as appropriate. For example, in some examples, the devices may be used in a non-percutaneous procedure. Devices and methods in accordance with the disclosure may also be adapted and configured for other uses within the anatomy.

FIGS. 1-2 illustrate selected components and/or arrangements of a left atrial appendage closure device system 10 which may be used for occluding a left atrial appendage. It should be noted that in any given figure, some features of the left atrial appendage closure device system 10 may not be shown, or may be shown schematically, for simplicity. Additional details regarding some of the components of the left atrial appendage closure device system 10 may be illustrated in other figures in greater detail.

The left atrial appendage closure device system 10 may include a delivery sheath 40 having a lumen 42 extending from a proximal opening to a distal opening, a core wire 30 slidably disposed within the lumen 42, and a left atrial appendage closure device 100 for occluding the left atrial appendage. The left atrial appendage closure device 100 may include an expandable framework 110 (e.g., FIG. 3) configured to shift between a fully constrained configuration (e.g., FIG. 1), wherein the left atrial appendage closure device 100 is disposed within the lumen 42 proximate the distal opening in the delivery configuration, and a fully unconstrained configuration (e.g., FIG. 2), wherein the left atrial appendage closure device 100 and/or the expandable framework 110 is configured to shift between the fully constrained configuration and the fully unconstrained configuration as the left atrial appendage closure device 100 is translated relative to the delivery sheath 40. In at least some embodiments, the expandable framework 110 may be self-biased toward the fully unconstrained configuration.

The left atrial appendage closure device 100 may be disposed at and/or releasably securable to a distal portion of the core wire 30. The core wire 30 may be slidably and/or rotatably disposed within the lumen 42 of the delivery sheath 40. In some embodiments, a proximal end of the core wire 30 may extend proximally of a proximal end of the delivery sheath 40 and/or the proximal opening of the lumen 42 for manual manipulation by a clinician or practitioner. In some embodiments, the left atrial appendage closure device 100 may be removably attached, joined, secured, or otherwise connected to a distal end of the core wire 30. The core wire 30 may be configured to and/or may be capable of axially translating the left atrial appendage closure device 100 relative to the delivery sheath 40. In one example, the core wire 30 may be advanced distally while the delivery sheath 40 is held in a constant position. In another example, the core wire 30 may be advanced distally while the delivery sheath 40 is retracted proximally. In yet another example, the core wire 30 may be held in a constant position while the delivery sheath 40 is retracted proximally relative to the core wire 30 and/or the left atrial appendage closure device 100. Other configurations are also contemplated. The delivery sheath 40 and/or the core wire 30 may have a selected level of axial stiffness and/or pushability characteristics while also having a selected level of flexibility to permit navigation through the patient's vasculature.

Some suitable, but non-limiting, examples of materials for the left atrial appendage closure device system 10, the core wire 30, the delivery sheath 40, and/or the left atrial appendage closure device 100, etc. are discussed below. It is contemplated that any exemplary left atrial appendage closure device disclosed herein may be used in accordance with and/or be associated with the example left atrial appendage closure device system 10 described above.

The left atrial appendage closure device 100 may comprise an expandable framework 110 configured to shift axially and/or radially along a central longitudinal axis between the fully constrained configuration and the fully unconstrained configuration. In the fully constrained configuration, the expandable framework 110 may be axially elongated and/or radially compressed. In the fully unconstrained configuration, the expandable framework 110 may be axially shortened and/or radially expanded.

As seen in FIG. 3, which illustrates selected aspects of the left atrial appendage closure device 100 in the fully unconstrained configuration, the expandable framework 110 may have a plurality of struts disposed about the central longitudinal axis. In some embodiments, the plurality of struts may define a plurality of cells. In some embodiments, the plurality of cells may be a plurality of closed cells. In some embodiments, the plurality of cells may be a plurality of open cells. In some embodiments, the plurality of cells may include a plurality of open cells and a plurality of closed cells in various combinations and/or arrangements. FIG. 3 illustrates that the expandable framework 110 may include a first grouping of cells 113, a first row of cells 129, a first strut segment 115, a second strut segment 117, a first node 119, a second grouping of cells 121, a second row 131, a third strut segment 123, a fourth strut segment 125, and a second node 127.

The expandable framework 110 may include a proximal hub 112 and a distal hub 114. In some embodiments, the proximal hub 112 and/or the distal hub 114 may be centered on and/or coaxial with the longitudinal axis. The plurality of struts may be joined together at and/or fixedly attached to the proximal hub 112 and/or the distal hub 114. The proximal hub 112 may be configured to releasably connect, secure, and/or attach the left atrial appendage closure device 100 and/or the expandable framework 110 to the core wire 30. In some embodiments, the proximal hub 112 may include internal threads configured to rotatably and/or threadably engage an externally threaded distal end of the core wire 30. Other configurations for releasably securing the left atrial appendage closure device 100 to the core wire 30 are also contemplated. As noted herein, some features are not shown in every figure to improve clarity.

The expandable framework 110 and/or the plurality of struts may be formed and/or cut from a tubular member. In some embodiments, the expandable framework 110 and/or the plurality of struts may be integrally formed and/or cut from a unitary member. In some embodiments, the expandable framework 110 and/or the plurality of struts may be integrally formed and/or cut from a unitary tubular member and subsequently formed and/or heat set to a desired shape in the fully unconstrained configuration. In some embodiments, the expandable framework 110 and/or the plurality of struts may be integrally formed and/or cut from a unitary flat member or sheet, and then rolled or formed into a tubular structure and subsequently formed and/or heat set to the desired shape in the fully unconstrained configuration. Some exemplary means and/or methods of making and/or forming the expandable framework 110 and/or the plurality of struts include laser cutting, machining, punching, stamping, electro discharge machining (EDM), chemical dissolution, etc. Other means and/or methods are also contemplated.

As would be understood by the skilled person, anatomical features may vary in size and/or shape. In some embodiments, the left atrial appendage may have an irregular (e.g., elongated and/or oblong) cross-sectional shape. In some embodiments, the expandable framework 110 may be compliant and substantially conform to and/or be in sealing engagement with the shape and/or geometry of a lateral wall of a left atrial appendage when deployed and/or expanded therein. In some embodiments, the left atrial appendage closure device 100 may expand to a size, extent, or shape less than or different from the fully unconstrained configuration, as determined by the surrounding tissue and/or lateral wall of the left atrial appendage. In some embodiments, the expandable framework 110 may be configured to shape and/or stretch the tissue of the left atrial appendage such that the lateral wall of the left atrial appendage substantially conforms to an outer shape of the expandable framework 110. Other configurations are also contemplated.

In some embodiments, the expandable framework 110 may include at least one anchoring member 116 extending radially outward therefrom in the fully unconstrained configuration. In some embodiments, the expandable framework 110 may include at least one anchoring member 116 extending radially outward from the expandable framework 110. In some embodiments, the expandable framework 110 may include at least one anchoring member 116 extending radially outward from the expandable framework 110 proximate a proximal shoulder of the expandable framework 110. In some embodiments, the expandable framework 110 may include at least one anchoring member 116 extending radially outward from the expandable framework 110 proximate a midsection of the expandable framework 110. In some embodiments, the at least one anchoring member 116 may be configured to engage with the lateral wall of the main body of the left atrial appendage. In some embodiments, the at least one anchoring member 116 may be formed as J-shaped hooks having a free end extending in and/or directed toward a proximal direction with respect to the central longitudinal axis of the left atrial appendage closure device 100 and/or the expandable framework 110. Other configurations are also contemplated.

In some embodiments, the left atrial appendage closure device 100 may optionally include the occlusive element 120 connected to, disposed on, disposed over, disposed about, and/or disposed radially outward of at least a portion of the expandable framework 110 and/or the plurality of struts, as seen in FIG. 4. In some embodiments, the occlusive element 120 may be attached to the proximal hub 112 and/or may be attached to the expandable framework at the proximal hub 112. In some embodiments, the occlusive element 120 may extend radially outward from and/or may extend distally from the proximal hub 112. In some embodiments, the occlusive element 120 may be attached and/or secured to the expandable framework 110 at a plurality of discrete locations. In some embodiments, one of, some of, and/or all of the at least one anchoring member 116 may extend through an occlusive element 120, where present.

In some embodiments, the occlusive element 120 may include a membrane, a fabric, a mesh, a tissue element, or another suitable construction. In some embodiments, the occlusive element 120 may be porous. In some embodiments, the occlusive element 120 may be non-porous. In some embodiments, the occlusive element 120 may be permeable to selected gases and/or fluids. In some embodiments, the occlusive element 120 may be substantially impermeable to selected gases and/or fluids, such as blood, water, etc. In some embodiments, the occlusive element 120 may be designed, sized, and/or configured to prevent thrombus and/or embolic material from passing out of the left atrial appendage into the left atrium and/or the patient's bloodstream. In some embodiments, the occlusive element 120 may be configured to promote endothelization after implantation, thereby effectively removing the target site (e.g., the left atrial appendage, etc.) from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusive element 120 are discussed below.

FIGS. 5-9 schematically illustrate selected aspects of the left atrial appendage closure device 100 and/or the left atrial appendage closure device system 10 during deployment of the left atrial appendage closure device 100. For clarity and ease of understanding, some elements of the left atrial appendage closure device 100 are not shown but shall be understood to be present in accordance and/or consistent with other figures and/or description of the disclosure. FIGS. 5-8 illustrate the left atrial appendage closure device 100 in partial cross-section. FIG. 9 illustrates the left atrial appendage closure device 100 using broken lines to show hidden features as may be understood from other figures. The occlusive element 120 is not shown in FIG. 9. It may be seen in FIGS. 5-9 that as the expandable framework 110 of the left atrial appendage closure device 100 shifts from fully constrained to fully unconstrained, the expandable framework 110 may transition sequentially through a plurality of positions. In some embodiments, the plurality of positions may include a first position, a second position, a third position, a fourth position, and/or a fifth position as described herein. In some embodiments, the plurality of positions may include additional and/or other positions.

Returning now to FIG. 5, in some embodiments, the expandable framework 110 may be fully constrained in a first position by the delivery sheath 40. In some embodiments, the expandable framework 110 may be disposed within the lumen 42 of the delivery sheath 40 in the first position. In some embodiments, in the first position a first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114 substantially parallel to the central longitudinal axis to a first bend 132 and a second segment 140 of the plurality of struts of the expandable framework 110 may extend from the first bend 132 proximally. In some embodiments, in the first position the second segment 140 may extend from the first bend 132 proximally and generally parallel to the central longitudinal axis. In the first position, the distal hub 114 may be disposed proximal of the first bend 132. In some embodiments, the first segment 130 may be secured to the distal hub 114. In some embodiments, the first segment 130 may be fixedly attached to the distal hub 114. For example, the first segment 130 may be welded, adhesively bonded, etc. to the distal hub 114. Other configurations are also contemplated.

In some embodiments, relative axial translation between the delivery sheath 40 and the expandable framework 110 may expose some of the expandable framework 110 and/or the plurality of struts in a second position, as seen in FIG. 6. In some embodiments, a first amount of the expandable framework 110 and/or the plurality of struts may be exposed from and/or unconstrained by the delivery sheath 40 in the second position. In some embodiments, the first amount may be less than about 55% of an axial length, a volume, a weight, and/or a surface area of the expandable framework 110 and/or the plurality of struts. In some embodiments, the first amount may be about 15% to about 55% of the axial length, the volume, the weight, and/or the surface area of the expandable framework 110 and/or the plurality of struts. Other configurations and/or ranges are also contemplated. In some embodiments, in the second position, the expandable framework 110 may have a maximum radial extent of about 6 millimeters (mm) to about 10 mm. In some embodiments, in the second position, the expandable framework 110 may have a maximum radial extent of about 8 mm. In some embodiments, in the second position, the maximum radial extent of the expandable framework 110 may be about twice or about 200% of a maximum outer extent of a distal end of the delivery sheath 40. Other configurations and/or sizes are also contemplated.

In some embodiments, in the second position the first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114 substantially parallel to the central longitudinal axis to the first bend 132. In the second position, the second segment 140 of the plurality of struts of the expandable framework 110 may extend from the first bend 132 proximally and radially outward toward and/or to a second bend 142. In the second position, a third segment 150 of the plurality of struts of the expandable framework 110 may extend from the second bend 142 proximally and radially inward toward and/or to a third bend 152. In some embodiments, in the second position, a fourth segment 160 of the plurality of struts of the expandable framework 110 may extend from the third bend 152 proximally to within the lumen 42 of the delivery sheath 40. In some embodiments, in the second position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend from the third bend 152 proximally toward the proximal hub 112 disposed within the lumen 42 of the delivery sheath 40.

In some embodiments, in the second position, the distal hub 114 is disposed proximal of the first bend 132. In some embodiments, in the second position, the distal hub 114 may be disposed distal of the second bend 142. For example, in the second position, the distal hub 114 may be positioned distal of a plane extending through, including at least a portion of, and/or tangent to the second bend 142 and oriented perpendicular to the central longitudinal axis. In some embodiments, in the second position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form and/or intersect to form an acute angle opening inwardly toward an interior of the expandable framework 110. In some embodiments, in the second position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form and/or intersect to form an acute angle opening radially outwardly from the central longitudinal axis. In some embodiments, in the second position, the second segment 140 of the plurality of struts of the expandable framework 110, if swept circumferentially around the central longitudinal axis, may define a generally conical shape tapering radially outward in a proximal direction from the first bend 132 toward the second bend 142.

In some embodiments, relative axial translation between the delivery sheath 40 and the expandable framework 110 may expose more of the expandable framework 110 and/or the plurality of struts in a third position than in the second position, as seen in FIG. 7. In some embodiments, a second amount of the expandable framework 110 and/or the plurality of struts greater than the first amount may be exposed from and/or unconstrained by the delivery sheath 40 in the third position. In some embodiments, the second amount may be less than about 75% of the axial length, the volume, the weight, and/or the surface area of the expandable framework 110 and/or the plurality of struts. In some embodiments, the second amount may be about 40% to about 75% of the axial length, the volume, the weight, and/or the surface area of the expandable framework 110 and/or the plurality of struts. Other configurations and/or ranges are also contemplated.

In some embodiments, in the third position the first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114 substantially parallel to the central longitudinal axis to the first bend 132. In the third position, the second segment 140 of the plurality of struts of the expandable framework 110 may extend from the first bend 132 radially outward generally perpendicular to the central longitudinal axis toward and/or to the second bend 142. In the third position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend from the second bend 142 proximally and radially inward toward and/or to the third bend 152. In some embodiments, in the third position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend from the third bend 152 proximally to within the lumen 42 of the delivery sheath 40. In some embodiments, in the third position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend from the third bend 152 proximally toward the proximal hub 112 disposed within the lumen 42 of the delivery sheath 40.

In some embodiments, in the third position, the distal hub 114 is disposed proximal of the first bend 132. In some embodiments, in the third position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form and/or intersect to form a generally right angle opening toward the interior of the expandable framework 110. In some embodiments, in the third position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form and/or intersect to form a generally right angle opening radially outwardly away from the central longitudinal axis. In some embodiments, in the third position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may form and/or intersect to form an acute angle opening radially inwardly toward the interior of the expandable framework 110. In some embodiments, in the third position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may form and/or intersect to form an acute angle opening radially inwardly toward the central longitudinal axis. In some embodiments, in the third position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may form and/or intersect to form an obtuse angle opening radially outwardly away from the central longitudinal axis. In some embodiments, in the third position, the second segment 140 of the plurality of struts of the expandable framework 110, if swept circumferentially around the central longitudinal axis, may define a generally planar shape oriented generally perpendicular to the central longitudinal axis.

In some embodiments, relative axial translation between the delivery sheath 40 and the expandable framework 110 may expose more of the expandable framework 110 and/or the plurality of struts in a fourth position than in the third position, as seen in FIG. 8. In some embodiments, a third amount of the expandable framework 110 and/or the plurality of struts greater than the second amount may be exposed from and/or unconstrained by the delivery sheath 40 in the fourth position. In some embodiments, the third amount may be less than about 95% of the axial length, the volume, the weight, and/or the surface area of the expandable framework 110 and/or the plurality of struts. In some embodiments, the third amount may be about 60% to about 95% of the axial length, the volume, the weight, and/or the surface area of the expandable framework 110 and/or the plurality of struts. Other configurations and/or ranges are also contemplated.

In some embodiments, in the fourth position the first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114 substantially parallel to the central longitudinal axis to the first bend 132. In the fourth position, the second segment 140 of the plurality of struts of the expandable framework 110 may extend from the first bend 132 distally and radially outward toward and/or to the second bend 142. In the fourth position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend from the second bend 142 proximally and radially inward toward and/or to the third bend 152. In some embodiments, in the fourth position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend from the third bend 152 proximally toward the proximal hub 112 disposed within the lumen 42 of the delivery sheath 40.

In some embodiments, in the fourth position, the distal hub 114 is disposed proximal of the first bend 132. In some embodiments, in the fourth position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form and/or intersect to form an obtuse angle opening inwardly toward the interior of the expandable framework 110. In some embodiments, in the fourth position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may form and/or intersect to form an acute angle opening radially inwardly toward the central longitudinal axis. In some embodiments, in the fourth position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may form and/or intersect to form an obtuse angle opening radially outwardly away from the central longitudinal axis. In some embodiments, in the fourth position, the second segment 140 of the plurality of struts of the expandable framework 110, if swept circumferentially around the central longitudinal axis, may define a generally conical shape tapering radially outward in a distal direction from the first bend 132 toward the second bend 142.

In some embodiments, relative axial translation between the delivery sheath 40 and the expandable framework 110 may expose substantially all of the expandable framework 110 and/or the plurality of struts in a fifth position, as seen in FIG. 9. In some embodiments, a fourth amount of the expandable framework 110 and/or the plurality of struts greater than the third amount may be exposed from and/or unconstrained by the delivery sheath 40 in the fifth position. In some embodiments, the fourth amount may be more than about 95% of the axial length, the volume, the weight, and/or the surface area of the expandable framework 110 and/or the plurality of struts. In some embodiments, the fourth amount may be about 100% of the axial length, the volume, the weight, and/or the surface area of the expandable framework 110 and/or the plurality of struts. Other configurations and/or ranges are also contemplated.

In some embodiments, the expandable framework 110 may be in the fully unconstrained configuration in the fifth position. In some embodiments, in the fully unconstrained configuration, the expandable framework may have a maximum radial extent of about 16 millimeters (mm) to about 40 mm. In some embodiments, in the fully unconstrained configuration, the expandable framework may have a maximum radial extent of about 16 mm. In some embodiments, in the fully unconstrained configuration, the expandable framework may have a maximum radial extent of about 20 mm. In some embodiments, in the fully unconstrained configuration, the expandable framework may have a maximum radial extent of about 25 mm. In some embodiments, in the fully unconstrained configuration, the expandable framework may have a maximum radial extent of about 30 mm. In some embodiments, in the fully unconstrained configuration, the expandable framework may have a maximum radial extent of about 35 mm. In some embodiments, in the fully unconstrained configuration, the expandable framework may have a maximum radial extent of about 40 mm. Other configurations and/or sizes are also contemplated.

In some embodiments, in the fifth position the first segment 130 of the plurality of struts of the expandable framework 110 may extend distally from the distal hub 114 substantially parallel to the central longitudinal axis to the first bend 132. In the fifth position, the second segment 140 of the plurality of struts of the expandable framework 110 may extend from the first bend 132 distally and radially outward toward and/or to the second bend 142. In the fifth position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend from the second bend 142 proximally and toward and/or to the third bend 152. In some embodiments, the fifth position, the third segment 150 of the plurality of struts of the expandable framework 110 may extend from the second bend 142 proximally generally parallel to the central longitudinal axis toward and/or to the third bend 152. In some embodiments, in the fifth position, the fourth segment 160 of the plurality of struts of the expandable framework 110 may extend from the third bend 152 radially inward toward and/or to the proximal hub 112.

In some embodiments, in the fifth position, the distal hub 114 is disposed proximal of the first bend 132. In some embodiments, in the fifth position, the first segment 130 of the plurality of struts and the second segment 140 of the plurality of struts may form and/or intersect to form an obtuse angle opening inwardly toward the interior of the expandable framework 110. In some embodiments, in the fifth position, the second segment 140 of the plurality of struts and the third segment 150 of the plurality of struts may form and/or intersect to form an acute angle opening radially inwardly toward the central longitudinal axis. In some embodiments, in the fifth position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may form and/or intersect to form an angle of about 90 degrees or less opening radially inwardly toward the interior of the expandable framework 110. In some embodiments, in the fifth position, the third segment 150 of the plurality of struts and the fourth segment 160 of the plurality of struts may form and/or intersect to form an angle of about 90 degrees or less opening radially inwardly toward the central longitudinal axis.

A method for occluding the left atrial appendage may comprise advancing the left atrial appendage closure device 100 into the left atrial appendage of the patient's heart. For example, the left atrial appendage closure device 100 may be advanced to the left atrial appendage within the lumen 42 of the delivery sheath 40 in the fully constrained configuration. The method may include deploying the expandable framework 110 from the delivery sheath 40 within the left atrial appendage. The method may further include expanding and/or shifting the expandable framework 110 from the fully constrained configuration toward the fully unconstrained configuration within the left atrial appendage.

As the expandable framework 110 shifts from fully constrained to fully unconstrained, the expandable framework 110 may transition sequentially through a plurality of positions, as described herein. In some embodiments, in the second position, the expandable framework 110 may be moved and/or navigated within the patient's heart, the left atrium, and/or the left atrial appendage. In the second position, the expandable framework 110 may form a generally rounded atraumatic shape. In some embodiments, in the second position, the maximum radial extent of the expandable framework 110 may be about twice or about 200% of a maximum outer extent of a distal end of the delivery sheath 40. In some embodiments, in the second position, the maximum radial extent of the expandable framework 110 may be about 8 millimeters. Other configurations and/or sizes are also contemplated. In some embodiments, a physician may use the generally rounded atraumatic shape as a navigational tool within the patient's anatomy.

In and/or near the fully unconstrained configuration (e.g., the fifth position), the expandable framework 110 may be urged into contact with, engaged with, and/or anchored to the lateral wall of the main body of the left atrial appendage. In some embodiments, the expandable framework 110 may not fully achieve the fully unconstrained configuration (e.g., the fifth position) due to contact with the wall(s) of the left atrial appendage. However, the inverted shape of the distal portion of the expandable framework 110 (e.g., the first segment 130, the first bend 132, the second segment 140, and the second bend 142) may prevent the expandable framework 110 from elongating distally, which may compromise locating the left atrial appendage closure device 100 and/or the expandable framework 110 within the left atrial appendage, sealing of the left atrial appendage closure device 100 and/or the expandable framework 110 with respect to the left atrial appendage, and/or anchoring of the left atrial appendage closure device 100 and/or the expandable framework 110 within the left atrial appendage. Instead, compressive force applied against the third segment 150 and/or the second bend 142 may urge the distal hub 114 proximally toward the proximal hub 112. As such, the final shape of the left atrial appendage closure device 100 and/or the expandable framework 110 may be more predictable and locating and anchoring of the left atrial appendage closure device 100 and/or the expandable framework 110 within the left atrial appendage may be improved.

In at least some embodiments, the left atrial appendage closure device 100 and/or the expandable framework 110 may span across the ostium of the left atrial appendage. In some embodiments, the left atrial appendage closure device 100 and/or the expandable framework 110 may span completely across the ostium of the left atrial appendage, thereby effectively removing the left atrial appendage from the circulatory system of the patient.

When satisfied with the positioning of the left atrial appendage closure device 100 within the left atrial appendage, the core wire 30 may be disconnected from the left atrial appendage closure device 100, thereby leaving the left atrial appendage closure device 100 disposed at and/or in the left atrial appendage. In some embodiments, disconnecting the core wire 30 from the left atrial appendage closure device 100 may include rotating the externally threaded distal end of the core wire 30 relative to the left atrial appendage closure device 100 and/or the proximal hub 112 to disengage the core wire 30 from the left atrial appendage closure device 100.

In some embodiments, the delivery sheath 40 and/or the core wire 30 may include a keying structure configured to prevent rotation of the core wire 30 relative to the proximal hub 112. In such embodiments, the keying structure is disengaged prior to rotating the core wire 30 relative to the left atrial appendage closure device 100 and/or the proximal hub 112. When the keying structure is engaged, rotation of the core wire 30 may be transmitted to left atrial appendage closure device 100 and/or the expandable framework 110. In some embodiments, rotation of the left atrial appendage closure device 100 and/or the expandable framework 110 may facilitate positioning and/or orientation of the left atrial appendage closure device 100 and/or the expandable framework 110 relative to the left atrial appendage, for example, with respect to an asymmetrical and/or irregular ostium and/or left atrial appendage. Other configurations, purposes, and/or results are also contemplated.

The materials that can be used for the various components of the system (and/or other elements disclosed herein) and the various components thereof disclosed herein may include those commonly associated with medical devices and/or systems. For simplicity purposes, the following discussion refers to the system. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the left atrial appendage closure device, the delivery sheath, the core wire, the expandable framework, the occlusive element, etc. and/or elements or components thereof.

In some embodiments, the system and/or components thereof may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material.

Some examples of suitable metals and metal alloys include stainless steel, such as 444V, 444L, and 314LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

As alluded to herein, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super-elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear than the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super-elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super-elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.

In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the system and/or other elements disclosed herein may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user in determining the location of the system and/or other elements disclosed herein. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the system and/or other elements disclosed herein to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the system and/or other elements disclosed herein. For example, the system and/or components or portions thereof may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The system or portions thereof, may also be made from a material that the MM machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the system and/or other elements disclosed herein may be made from or include a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly praraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

In some embodiments, the system and/or other elements disclosed herein may include a fabric material disposed over or within the structure. The fabric material may be composed of a biocompatible material, such a polymeric material or biomaterial, adapted to promote tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), a polyolefinic material such as a polyethylene, a polypropylene, polyester, polyurethane, and/or blends or combinations thereof.

In some embodiments, the system and/or other elements disclosed herein may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.

In some embodiments, the system and/or other elements disclosed herein may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vasoactive mechanisms.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The disclosure's scope is, of course, defined in the language in which the appended claims are expressed.

Claims

1. A medical implant, comprising:

an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub;
wherein the plurality of struts of the expandable framework are formed from a unitary tubular member:
wherein the expandable framework includes a proximal shoulder region extending from the proximal hub to a proximal shoulder region end point, and wherein the expandable framework includes a distal shoulder region extending from the distal hub to a distal shoulder region end point; and
wherein the portion of the expandable framework extending between the proximal shoulder region end point and the distal shoulder region end point is substantially parallel to the central longitudinal axis; and
wherein the plurality of struts extending between the proximal hub and the distal hub define an interior volume of the expandable framework, and wherein the proximal hub is located outside the interior volume of the expandable framework and the distal hub is located within the interior volume of the expandable framework;
wherein in a fully unconstrained configuration of the expandable framework, a first segment of the plurality of struts extends distally from the distal hub to a first bend, and a second segment of the plurality of struts extends from the first bend distally and radially outward to a second bend.

2. The medical implant of claim 1, wherein the proximal shoulder region includes a first grouping of cells adjacent to the proximal hub and defining a first row, and wherein a first cell in the first row of cells includes a first strut segment and a second strut segment joined at a first distal node.

3. The medical implant of claim 2, wherein the first row of cells extends circumferentially around the central longitudinal axis of the expandable framework.

4. The medical implant of claim 3, wherein the expandable framework further includes a second grouping of cells defining a second row adjacent to the first row, and wherein a second cell in the second row of cells includes a third strut segment and a fourth strut segment joined at a second distal node.

5. The medical device of claim 4, wherein the width of at least one cell of the second grouping of cells is different than the width of the cells defining the first grouping of cells.

6. The medical device of claim 5, wherein the width of at least one cell of the second grouping of cells is wider than the width of the cells defining the first grouping of cells.

7. The medical implant of claim 1, further comprising a membrane disposed along an outer surface of the expandable framework.

8. The medical implant of claim 7, wherein the membrane extends along the outer surface of the expandable framework from the proximal hub to a membrane end point, and wherein the membrane end point is positioned along the portion of the expandable framework that is substantially parallel to the central longitudinal axis.

9. The medical implant of claim 8, wherein the membrane end point is positioned at a second node of the second grouping of cells.

10. The medical implant of claim 1, wherein the expandable framework further includes a plurality of fixation members disposed thereon.

11. The medical implant of claim 10, wherein the plurality of fixation members are formed from the unitary tubular member.

12. The medical implant of claim 11, wherein at least a portion of the plurality of fixation members extend through an aperture formed in the membrane.

13. The medical implant of claim 1, wherein the plurality of struts extending between the proximal hub and the distal hub define an interior volume of the expandable framework, and wherein the proximal hub is located outside the interior volume of the expandable framework and the distal hub is located within the interior volume of the expandable framework, and wherein when in the expanded configuration, the distal hub is positioned proximal of a distalmost extent of the expandable framework.

14. The medical implant of claim 1, wherein the expandable framework is configured to shift between a first unexpanded configuration and an expanded configuration, and wherein when in the expanded configuration, the distal hub is positioned proximal of a distalmost extent of the expandable framework.

15. An occlusive implant, comprising:

an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub;
wherein the plurality of struts of the expandable framework are formed from a unitary tubular member;
wherein the expandable framework includes a proximal shoulder region extending from the proximal hub to a proximal shoulder region end point; and
wherein the expandable framework includes a distal shoulder region extending from the distal hub to a distal shoulder region end point; and
wherein the portion of the expandable framework extending between the proximal shoulder region end point and the distal shoulder region end point is substantially parallel to the central longitudinal axis; and
wherein the plurality of struts extending between the proximal hub and the distal hub define an interior volume of the expandable framework, and wherein the proximal hub is located outside the interior volume of the expandable framework and the distal hub is located within the interior volume of the expandable framework;
wherein when the expandable framework is disposed within a delivery sheath in a fully constrained configuration, a first segment of the plurality of struts extends distally from the distal hub to a first bend, and a second segment of the plurality of struts extends from the first bend proximally;
wherein in a fully unconstrained configuration of the expandable framework, the first segment of the plurality of struts extends distally from the distal hub to the first bend, and the second segment of the plurality of struts extends from the first bend distally and radially outward to a second bend;
a membrane disposed along an outer surface of the expandable framework, wherein the membrane extends along the outer surface of the expandable framework from the proximal hub to a membrane end point; and
a plurality of fixation members disposed along the expandable framework.

16. The occlusive implant of claim 15, wherein the membrane end point is positioned along the portion of the expandable framework that is substantially parallel to the central longitudinal axis.

17. The occlusive implant of claim 16, wherein the expandable framework and the plurality of fixation members are formed from a unitary tubular member.

18. The occlusive implant of claim 17, wherein at least a portion of the plurality of fixation members extend through an aperture formed in the membrane.

19. The occlusive implant of claim 15, wherein the plurality of struts extending between the proximal hub and the distal hub define an interior volume of the expandable framework, and wherein the proximal hub is located outside the interior volume of the expandable framework and the distal hub is located within the interior volume of the expandable framework.

20. A method for occluding a left atrial appendage of a patient, the method comprising:

positioning an occlusive implant adjacent the left atrial appendage, the occlusive implant including: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub; wherein the plurality of struts of the expandable framework are formed from a unitary tubular member; wherein the expandable framework includes a proximal shoulder region extending from the proximal hub to a proximal shoulder region end point; and wherein the expandable framework includes a distal shoulder region extending from the distal hub to a distal shoulder region end point, and wherein the portion of the expandable framework extending between the proximal shoulder region end point and the distal shoulder region end point is substantially parallel to the central longitudinal axis; and wherein the plurality of struts extending between the proximal hub and the distal hub define an interior volume of the expandable framework, and wherein the proximal hub is located outside the interior volume of the expandable framework and the distal hub is located within the interior volume of the expandable framework; wherein in a fully unconstrained configuration of the expandable framework, a first segment of the plurality of struts extends distally from the distal hub to a first bend, and a second segment of the plurality of struts extends from the first bend distally and radially outward to a second bend; a membrane disposed along an outer surface of the expandable framework, wherein the membrane extends along the outer surface of the expandable framework from the proximal hub to a membrane end point; and a plurality of fixation members disposed along the expandable framework; and
expanding the occlusive implant within the left atrial appendage such that the membrane extends across an ostium of the left atrial appendage.
Referenced Cited
U.S. Patent Documents
178283 June 1876 French
1967318 July 1934 Monahan
3402710 September 1968 Paleschuck
3540431 November 1970 Mobin-Uddin
3557794 January 1971 Van Patten
3638652 February 1972 Kelley
3811449 May 1974 Gravlee et al.
3844302 October 1974 Klein
3874388 April 1975 King et al.
4007743 February 15, 1977 Blake
4108420 August 22, 1978 West et al.
4175545 November 27, 1979 Termanini
4309776 January 12, 1982 Berguer
4341218 July 27, 1982 Ü
4364392 December 21, 1982 Strother et al.
4425908 January 17, 1984 Simon
4545367 October 8, 1985 Tucci
4585000 April 29, 1986 Hershenson
4603693 August 5, 1986 Conta et al.
4611594 September 16, 1986 Grayhack et al.
4619246 October 28, 1986 Molgaard-Nielsen et al.
4638803 January 27, 1987 Rand et al.
4665906 May 19, 1987 Jervis
4681588 July 21, 1987 Ketharanathan et al.
4710192 December 1, 1987 Liotta et al.
4718417 January 12, 1988 Kittrell et al.
4759348 July 26, 1988 Cawood et al.
4781177 November 1, 1988 Lebigot
4793348 December 27, 1988 Palmaz
4827907 May 9, 1989 Tashiro
4832055 May 23, 1989 Palestrant
4873978 October 17, 1989 Ginsburg
4917089 April 17, 1990 Sideris
4921484 May 1, 1990 Hillstead
4960412 October 2, 1990 Fink
4966150 October 30, 1990 Etienne et al.
4998972 March 12, 1991 Chin et al.
5037810 August 6, 1991 Saliba, Jr.
5041090 August 20, 1991 Scheglov et al.
5041093 August 20, 1991 Chu
5042707 August 27, 1991 Taheri
5053009 October 1, 1991 Herzberg
5064435 November 12, 1991 Porter
5071407 December 10, 1991 Termin et al.
5078736 January 7, 1992 Behl
5098440 March 24, 1992 Hillstead
5108418 April 28, 1992 Lefebvre
5108420 April 28, 1992 Marks
5108474 April 28, 1992 Riedy et al.
5116360 May 26, 1992 Pinchuk et al.
5122136 June 16, 1992 Guglielmi et al.
5171259 December 15, 1992 Inoue
5171383 December 15, 1992 Sagaye et al.
5176692 January 5, 1993 Wilk et al.
5192301 March 9, 1993 Kamiya et al.
5211658 May 18, 1993 Clouse
5234458 August 10, 1993 Metais
5256146 October 26, 1993 Ensminger et al.
5258000 November 2, 1993 Gianturco
5258042 November 2, 1993 Mehta
5279539 January 18, 1994 Bohan et al.
5284488 February 8, 1994 Sideris
5304184 April 19, 1994 Hathaway et al.
5306234 April 26, 1994 Johnson
5312341 May 17, 1994 Turi
5329942 July 19, 1994 Gunther et al.
5334217 August 2, 1994 Das
5344439 September 6, 1994 Otten
5350398 September 27, 1994 Pavcnik et al.
5350399 September 27, 1994 Erlebacher et al.
5353784 October 11, 1994 Nady-Mohamed
5366460 November 22, 1994 Eberbach
5366504 November 22, 1994 Andersen et al.
5370657 December 6, 1994 Irie
5375612 December 27, 1994 Cottenceau et al.
5397331 March 14, 1995 Himpens et al.
5397355 March 14, 1995 Marin et al.
5409444 April 25, 1995 Kensey et al.
5417699 May 23, 1995 Klein et al.
5421832 June 6, 1995 Lefebvre
5425744 June 20, 1995 Fagan et al.
5427119 June 27, 1995 Swartz et al.
5433727 July 18, 1995 Sideris
5443454 August 22, 1995 Tanabe et al.
5443478 August 22, 1995 Purdy et al.
5451235 September 19, 1995 Lock et al.
5454365 October 3, 1995 Bonutti
5464408 November 7, 1995 Duc
5469867 November 28, 1995 Schmitt
5490856 February 13, 1996 Person et al.
5497774 March 12, 1996 Swartz et al.
5499975 March 19, 1996 Cope et al.
5499995 March 19, 1996 Teirstein
5522790 June 4, 1996 Moll et al.
5522822 June 4, 1996 Phelps et al.
5522836 June 4, 1996 Palermo
5527322 June 18, 1996 Klein et al.
5527338 June 18, 1996 Purdy
5558093 September 24, 1996 Pomeranz et al.
5558652 September 24, 1996 Henke
5569204 October 29, 1996 Cramer et al.
5591196 January 7, 1997 Marin et al.
5614204 March 25, 1997 Cochrum
5634936 June 3, 1997 Linden et al.
5634942 June 3, 1997 Chevillon et al.
5637097 June 10, 1997 Yoon
5643282 July 1, 1997 Kieturakis
5643292 July 1, 1997 Hart
5649953 July 22, 1997 Lefebvre
5653690 August 5, 1997 Booth et al.
5662671 September 2, 1997 Barbut et al.
5669933 September 23, 1997 Simon et al.
5681345 October 28, 1997 Euteneuer
5681347 October 28, 1997 Cathcart et al.
5683411 November 4, 1997 Kavteladze et al.
5690671 November 25, 1997 McGurk et al.
5693067 December 2, 1997 Purdy
5695525 December 9, 1997 Mulhauser et al.
5700285 December 23, 1997 Myers et al.
5702421 December 30, 1997 Schneidt
5704910 January 6, 1998 Humes
5709224 January 20, 1998 Behl et al.
5709704 January 20, 1998 Nott et al.
5709707 January 20, 1998 Lock et al.
5722400 March 3, 1998 Ockuly et al.
5724975 March 10, 1998 Negus et al.
5725512 March 10, 1998 Swartz et al.
5725552 March 10, 1998 Kotula et al.
5725568 March 10, 1998 Hastings
5733294 March 31, 1998 Forber et al.
5733302 March 31, 1998 Myler et al.
5735290 April 7, 1998 Sterman et al.
5749880 May 12, 1998 Banas et al.
5749883 May 12, 1998 Halpern
5749894 May 12, 1998 Engelson
5766219 June 16, 1998 Horton
5766246 June 16, 1998 Mulhauser et al.
5769816 June 23, 1998 Barbut et al.
5776097 July 7, 1998 Massoud
5776162 July 7, 1998 Kleshinski
5782860 July 21, 1998 Epstein et al.
5785679 July 28, 1998 Abolfathi et al.
5800454 September 1, 1998 Jacobsen et al.
5800457 September 1, 1998 Gelbfish
5800512 September 1, 1998 Letnz et al.
5807261 September 15, 1998 Benaron et al.
5810874 September 22, 1998 Lefebvre
5814028 September 29, 1998 Swartz et al.
5814029 September 29, 1998 Hassett
5814064 September 29, 1998 Daniel
5820591 October 13, 1998 Thompson et al.
5823198 October 20, 1998 Jones et al.
5830228 November 3, 1998 Knapp et al.
5833673 November 10, 1998 Ockuly et al.
5836913 November 17, 1998 Orth et al.
5836968 November 17, 1998 Simon et al.
5840027 November 24, 1998 Swartz et al.
5843118 December 1, 1998 Sepetka et al.
5846260 December 8, 1998 Maahs
5846261 December 8, 1998 Kotula et al.
5848969 December 15, 1998 Panescu et al.
5849005 December 15, 1998 Garrison et al.
5851232 December 22, 1998 Lois
5853422 December 29, 1998 Huebsch et al.
5855597 January 5, 1999 Jayaraman
5865791 February 2, 1999 Whayne et al.
5865802 February 2, 1999 Yoon et al.
5868702 February 9, 1999 Stevens et al.
5868708 February 9, 1999 Hart et al.
5876367 March 2, 1999 Kaganov et al.
5879296 March 9, 1999 Ockuly et al.
5879366 March 9, 1999 Shaw et al.
5882340 March 16, 1999 Yoon
5885258 March 23, 1999 Sachdeva et al.
5891558 April 6, 1999 Bell et al.
5895399 April 20, 1999 Barbut et al.
5902289 May 11, 1999 Swartz et al.
5904680 May 18, 1999 Kordis et al.
5904703 May 18, 1999 Gilson
5906207 May 25, 1999 Shen
5910154 June 8, 1999 Tsugita et al.
5911734 June 15, 1999 Tsugita et al.
5916236 June 29, 1999 Muijs Van de Moer et al.
5925060 July 20, 1999 Forber
5925063 July 20, 1999 Khosravi
5925074 July 20, 1999 Gingras et al.
5925075 July 20, 1999 Myers et al.
5928192 July 27, 1999 Maahs
5928260 July 27, 1999 Chin et al.
5931818 August 3, 1999 Werp et al.
5935145 August 10, 1999 Villar et al.
5935147 August 10, 1999 Kensey et al.
5935148 August 10, 1999 Villar et al.
5941249 August 24, 1999 Maynard
5941896 August 24, 1999 Kerr
5944738 August 31, 1999 Amplatz et al.
5947997 September 7, 1999 Pavcnik et al.
5951589 September 14, 1999 Epstein et al.
5951599 September 14, 1999 McCrory
5954694 September 21, 1999 Sunseri
5954767 September 21, 1999 Pajotin et al.
5957940 September 28, 1999 Tanner et al.
5961545 October 5, 1999 Lentz et al.
5976174 November 2, 1999 Ruiz
5980514 November 9, 1999 Kupiecki et al.
5980555 November 9, 1999 Barbut et al.
5989281 November 23, 1999 Barbut et al.
5993469 November 30, 1999 McKenzie et al.
5993483 November 30, 1999 Gianotti
5997557 December 7, 1999 Barbut et al.
6004280 December 21, 1999 Buck et al.
6004348 December 21, 1999 Banas et al.
6007523 December 28, 1999 Mangosong
6007557 December 28, 1999 Ambrisco et al.
6010517 January 4, 2000 Baccaro
6010522 January 4, 2000 Barbut et al.
6013093 January 11, 2000 Nott et al.
6024751 February 15, 2000 Lovato et al.
6024754 February 15, 2000 Engelson
6024755 February 15, 2000 Addis
6024756 February 15, 2000 Huebsch et al.
6027520 February 22, 2000 Tsugita et al.
6033420 March 7, 2000 Hahnen
6036720 March 14, 2000 Abrams et al.
6042598 March 28, 2000 Tsugita et al.
6048331 April 11, 2000 Tsugita et al.
6051014 April 18, 2000 Jang
6051015 April 18, 2000 Maahs
6056720 May 2, 2000 Morse
6063070 May 16, 2000 Eder
6063113 May 16, 2000 Kavteladze et al.
6066126 May 23, 2000 Li et al.
6068621 May 30, 2000 Balceta et al.
6074357 June 13, 2000 Kaganov et al.
6076012 June 13, 2000 Swanson et al.
6079414 June 27, 2000 Roth
6080182 June 27, 2000 Shaw et al.
6080183 June 27, 2000 Tsugita et al.
6083239 July 4, 2000 Addis
6090084 July 18, 2000 Hassett et al.
6096052 August 1, 2000 Callister et al.
6096053 August 1, 2000 Bates et al.
6110243 August 29, 2000 Wnenchak et al.
6123715 September 26, 2000 Amplatz
6124523 September 26, 2000 Banas et al.
6132438 October 17, 2000 Fleischman et al.
6135991 October 24, 2000 Muni et al.
6136016 October 24, 2000 Barbut et al.
6139527 October 31, 2000 Laufer et al.
6139573 October 31, 2000 Sogard et al.
6152144 November 28, 2000 Lesh et al.
6152946 November 28, 2000 Broome et al.
6156055 December 5, 2000 Ravenscroft
6159195 December 12, 2000 Ha et al.
6161543 December 19, 2000 Cox et al.
6168615 January 2, 2001 Ken et al.
6171329 January 9, 2001 Shaw et al.
6179859 January 30, 2001 Bates et al.
6193739 February 27, 2001 Chevillon et al.
6203531 March 20, 2001 Ockuly et al.
6206907 March 27, 2001 Marino et al.
6214029 April 10, 2001 Thill et al.
6221092 April 24, 2001 Koike et al.
6231561 May 15, 2001 Frazier et al.
6231589 May 15, 2001 Wessman et al.
6235045 May 22, 2001 Barbut et al.
6245012 June 12, 2001 Kleshinski
6251122 June 26, 2001 Tsukernik
6258115 July 10, 2001 Dubrul
6267772 July 31, 2001 Mulhauser et al.
6267776 July 31, 2001 O'Connell
6270490 August 7, 2001 Hahnen
6270530 August 7, 2001 Eldridge et al.
6270902 August 7, 2001 Tedeschi et al.
6277138 August 21, 2001 Levinson et al.
6285898 September 4, 2001 Ben-Haim
6290674 September 18, 2001 Roue et al.
6290708 September 18, 2001 Kugel et al.
6312407 November 6, 2001 Zadno-Azizi et al.
6319251 November 20, 2001 Tu et al.
6328727 December 11, 2001 Frazier et al.
6328755 December 11, 2001 Marshall
6342062 January 29, 2002 Suon et al.
6346116 February 12, 2002 Brooks et al.
6346895 February 12, 2002 Lee et al.
6361545 March 26, 2002 Macoviak et al.
6364895 April 2, 2002 Greenhalgh
6368338 April 9, 2002 Kónya et al.
6371971 April 16, 2002 Tsugita et al.
6375670 April 23, 2002 Greenhalgh
6391044 May 21, 2002 Yadav et al.
6398803 June 4, 2002 Layne et al.
6402746 June 11, 2002 Whayne et al.
6402771 June 11, 2002 Palmer et al.
6402779 June 11, 2002 Colone et al.
6419669 July 16, 2002 Frazier et al.
6440152 August 27, 2002 Gainor et al.
6443972 September 3, 2002 Bosma et al.
6447530 September 10, 2002 Ostrovsky et al.
6454775 September 24, 2002 Demarais et al.
6458145 October 1, 2002 Ravenscroft et al.
6464712 October 15, 2002 Epstein et al.
6468291 October 22, 2002 Bates et al.
6468301 October 22, 2002 Amplatz et al.
6485501 November 26, 2002 Green
6488689 December 3, 2002 Kaplan et al.
6511496 January 28, 2003 Huter et al.
6514280 February 4, 2003 Gilson
6517573 February 11, 2003 Pollock et al.
6533782 March 18, 2003 Howell et al.
6547760 April 15, 2003 Samson et al.
6547815 April 15, 2003 Myers
6551303 April 22, 2003 Van Tassel et al.
6551344 April 22, 2003 Thill
6558401 May 6, 2003 Azizi
6558405 May 6, 2003 McInnes
6558414 May 6, 2003 Layne
6562058 May 13, 2003 Seguin et al.
6569184 May 27, 2003 Huter
6569214 May 27, 2003 Williams et al.
6589214 July 8, 2003 McGuckin et al.
6589251 July 8, 2003 Yee et al.
6599308 July 29, 2003 Amplatz
6602271 August 5, 2003 Adams et al.
6623508 September 23, 2003 Shaw et al.
6641564 November 4, 2003 Kraus
6650923 November 18, 2003 Lesh et al.
6652555 November 25, 2003 VanTassel et al.
6652556 November 25, 2003 VanTassel et al.
6666861 December 23, 2003 Grabek
6689150 February 10, 2004 Vantassel et al.
6699260 March 2, 2004 Dubrul et al.
6699276 March 2, 2004 Sogard et al.
6702825 March 9, 2004 Frazier et al.
6712836 March 30, 2004 Berg et al.
6726701 April 27, 2004 Gilson et al.
6730108 May 4, 2004 Van Tassel et al.
6755812 June 29, 2004 Peterson et al.
6827737 December 7, 2004 Hill et al.
6837901 January 4, 2005 Rabkin et al.
6855153 February 15, 2005 Saadat
6911037 June 28, 2005 Gainor et al.
6932838 August 23, 2005 Schwartz et al.
6942653 September 13, 2005 Quinn
6949113 September 27, 2005 Van Tassel et al.
6958061 October 25, 2005 Truckai et al.
6994092 February 7, 2006 van der Burg et al.
7011671 March 14, 2006 Welch
7014645 March 21, 2006 Greene, Jr. et al.
7037321 May 2, 2006 Sachdeva et al.
7044134 May 16, 2006 Khairkhahan et al.
7097651 August 29, 2006 Harrison et al.
7128073 October 31, 2006 van der Burg et al.
7152605 December 26, 2006 Khairkhahan et al.
7169164 January 30, 2007 Borillo et al.
7179275 February 20, 2007 McGuckin, Jr. et al.
7226466 June 5, 2007 Opolski
7303526 December 4, 2007 Sharkey et al.
7323002 January 29, 2008 Johnson et al.
7597704 October 6, 2009 Frazier et al.
7678123 March 16, 2010 Chanduszko
7695425 April 13, 2010 Schweich et al.
7713282 May 11, 2010 Frazier et al.
7722641 May 25, 2010 van der Burg et al.
7727189 June 1, 2010 VanTassel et al.
7735493 June 15, 2010 van der Burg et al.
7780694 August 24, 2010 Palmer et al.
7799049 September 21, 2010 Ostrovsky et al.
7811300 October 12, 2010 Feller, III et al.
7811314 October 12, 2010 Fierens et al.
7862500 January 4, 2011 Khairkhahan et al.
7927365 April 19, 2011 Fierens et al.
7972359 July 5, 2011 Kreidler
8025495 September 27, 2011 Hardert et al.
8043329 October 25, 2011 Khairkhahan et al.
8052715 November 8, 2011 Quinn et al.
8062282 November 22, 2011 Kolb
8080032 December 20, 2011 van der Burg et al.
8097015 January 17, 2012 Devellian
8100938 January 24, 2012 Figulla et al.
8221384 July 17, 2012 Frazier et al.
8221445 July 17, 2012 van Tassel et al.
8287563 October 16, 2012 Khairkhahan et al.
8323309 December 4, 2012 Khairkhahan et al.
8388672 March 5, 2013 Khairkhahan et al.
8491623 July 23, 2013 Vogel et al.
8523897 September 3, 2013 van der Burg et al.
8535343 September 17, 2013 van der Burg et al.
8562509 October 22, 2013 Bates
8663273 March 4, 2014 Khairkhahan et al.
8685055 April 1, 2014 VanTassel et al.
8728117 May 20, 2014 Janardhan et al.
8758389 June 24, 2014 Glimsdale
8828051 September 9, 2014 Javois et al.
8834519 September 16, 2014 van der Burg et al.
8845711 September 30, 2014 Miles et al.
9034006 May 19, 2015 Quinn et al.
9132000 September 15, 2015 VanTassel et al.
9168043 October 27, 2015 van der Burg et al.
9211124 December 15, 2015 Campbell et al.
9295472 March 29, 2016 Ottma
9351716 May 31, 2016 Miles et al.
9445895 September 20, 2016 Kreidler
9554804 January 31, 2017 Erzberger et al.
9554806 January 31, 2017 Larsen et al.
9561037 February 7, 2017 Fogarty et al.
9561097 February 7, 2017 Kim et al.
9592058 March 14, 2017 Erzberger et al.
9597088 March 21, 2017 Ottma
9629636 April 25, 2017 Fogarty et al.
9730701 August 15, 2017 Tischler et al.
9750505 September 5, 2017 Miles et al.
9763666 September 19, 2017 Wu et al.
9795387 October 24, 2017 Miles et al.
9808253 November 7, 2017 Li et al.
9883936 February 6, 2018 Sutton et al.
9913652 March 13, 2018 Bridgeman et al.
9943299 April 17, 2018 Khairkhahan et al.
9943315 April 17, 2018 Kaplan et al.
10071181 September 11, 2018 Penegor et al.
10076335 September 18, 2018 Zaver et al.
10143458 December 4, 2018 Kreidler
10201337 February 12, 2019 Glimsdale
10231737 March 19, 2019 Amplatz et al.
20010000797 May 3, 2001 Mazzocchi
20010020181 September 6, 2001 Layne
20010034537 October 25, 2001 Shaw et al.
20010037141 November 1, 2001 Yee et al.
20020022860 February 21, 2002 Borillo et al.
20020035374 March 21, 2002 Borillo et al.
20020045931 April 18, 2002 Sogard et al.
20020062133 May 23, 2002 Gilson et al.
20020082638 June 27, 2002 Porter et al.
20020082675 June 27, 2002 Myers
20020099439 July 25, 2002 Schwartz et al.
20020111647 August 15, 2002 Khairkhahan et al.
20020138094 September 26, 2002 Borillo et al.
20020138097 September 26, 2002 Ostrovsky et al.
20020169475 November 14, 2002 Gainor et al.
20020177855 November 28, 2002 Greene, Jr. et al.
20030017775 January 23, 2003 Dong et al.
20030023262 January 30, 2003 Welch
20030023266 January 30, 2003 Borillo et al.
20030057156 March 27, 2003 Peterson et al.
20030060871 March 27, 2003 Hill et al.
20030120337 June 26, 2003 Van Tassel et al.
20030181942 September 25, 2003 Sutton et al.
20030191526 October 9, 2003 Van Tassel et al.
20030195555 October 16, 2003 Khairkhahan et al.
20030204203 October 30, 2003 Khairkhahan et al.
20030208214 November 6, 2003 Loshakove et al.
20030220667 November 27, 2003 van der Burg et al.
20040034366 February 19, 2004 van der Burg et al.
20040049210 March 11, 2004 VanTassel et al.
20040093012 May 13, 2004 Cully et al.
20040098031 May 20, 2004 van der Burg et al.
20040122467 June 24, 2004 VanTassel et al.
20040127935 July 1, 2004 VanTassel et al.
20040158274 August 12, 2004 WasDyke
20040186486 September 23, 2004 Roue et al.
20040215230 October 28, 2004 Frazier et al.
20040220610 November 4, 2004 Kreidler et al.
20040220682 November 4, 2004 Levine et al.
20040230222 November 18, 2004 van der Burg et al.
20050004652 January 6, 2005 van der Burg et al.
20050015109 January 20, 2005 Lichtenstein
20050038470 February 17, 2005 van der Burg et al.
20050049573 March 3, 2005 Van Tassel et al.
20050070952 March 31, 2005 Devellian
20050113861 May 26, 2005 Corcoran et al.
20050125020 June 9, 2005 Meade et al.
20050177182 August 11, 2005 van der Burg et al.
20050203568 September 15, 2005 Burg et al.
20050283186 December 22, 2005 Berrada et al.
20050288704 December 29, 2005 Cartier et al.
20060015136 January 19, 2006 Besselink
20060030877 February 9, 2006 Martinez et al.
20060052816 March 9, 2006 Bates et al.
20060100658 May 11, 2006 Obana et al.
20060155323 July 13, 2006 Porter et al.
20070066993 March 22, 2007 Kreidler
20070083227 April 12, 2007 van der Burg et al.
20070083230 April 12, 2007 Javois
20070150041 June 28, 2007 Evans et al.
20070156123 July 5, 2007 Moll et al.
20070162048 July 12, 2007 Quinn et al.
20070185471 August 9, 2007 Johnson
20080275536 November 6, 2008 Zarins et al.
20090005803 January 1, 2009 Batiste
20090062841 March 5, 2009 Amplatz et al.
20090099647 April 16, 2009 Glimsdale et al.
20090105747 April 23, 2009 Chanduszko et al.
20090112249 April 30, 2009 Miles et al.
20090254195 October 8, 2009 Khairkhan et al.
20090318948 December 24, 2009 Linder et al.
20100004726 January 7, 2010 Hancock et al.
20100049238 February 25, 2010 Simpson
20100106178 April 29, 2010 Obermiller et al.
20100324585 December 23, 2010 Miles et al.
20110054515 March 3, 2011 Bridgeman
20110082495 April 7, 2011 Ruiz
20110098525 April 28, 2011 Kermode et al.
20110218566 September 8, 2011 van der Burg et al.
20110301630 December 8, 2011 Hendriksen et al.
20120029553 February 2, 2012 Quinn et al.
20120035643 February 9, 2012 Khairkhahan et al.
20120065662 March 15, 2012 van der Burg et al.
20120125619 May 24, 2012 Wood et al.
20120172654 July 5, 2012 Bates
20120172927 July 5, 2012 Campbell et al.
20120239077 September 20, 2012 Zaver et al.
20120239083 September 20, 2012 Kreidler
20120245619 September 27, 2012 Guest
20120283585 November 8, 2012 Werneth et al.
20120283773 November 8, 2012 Van Tassel et al.
20120323267 December 20, 2012 Ren
20130006343 January 3, 2013 Kassab et al.
20130012982 January 10, 2013 Khairkhahan et al.
20130018413 January 17, 2013 Oral et al.
20130110154 May 2, 2013 van der Burg et al.
20130165735 June 27, 2013 Khairkhahan et al.
20130211492 August 15, 2013 Schneider et al.
20130331884 December 12, 2013 Van der Burg et al.
20140005714 January 2, 2014 Quick et al.
20140018841 January 16, 2014 Peiffer et al.
20140039536 February 6, 2014 Cully et al.
20140046360 February 13, 2014 van der Burg et al.
20140081314 March 20, 2014 Zaver et al.
20140100596 April 10, 2014 Rudman et al.
20140135817 May 15, 2014 Tischler
20140142612 May 22, 2014 Li et al.
20140148842 May 29, 2014 Khairkhahan et al.
20140163605 June 12, 2014 VanTassel et al.
20140188157 July 3, 2014 Clark
20140214077 July 31, 2014 Glimsdale
20140296908 October 2, 2014 Ottma et al.
20140303719 October 9, 2014 Cox et al.
20140336612 November 13, 2014 Frydlewski et al.
20140336699 November 13, 2014 van der Burg et al.
20150005810 January 1, 2015 Center et al.
20150039021 February 5, 2015 Khairkhahan et al.
20150080903 March 19, 2015 Dillard et al.
20150196300 July 16, 2015 Tischler et al.
20150230909 August 20, 2015 Zaver et al.
20150238197 August 27, 2015 Quinn et al.
20150305727 October 29, 2015 Karimov et al.
20150313604 November 5, 2015 Roue et al.
20150313605 November 5, 2015 Griffin
20150327979 November 19, 2015 Quinn et al.
20150374491 December 31, 2015 Kreidler
20160015397 January 21, 2016 Figulla et al.
20160051358 February 25, 2016 Sutton et al.
20160058539 March 3, 2016 VanTassel et al.
20160066922 March 10, 2016 Bridgeman et al.
20160106437 April 21, 2016 van der Burg et al.
20160192942 July 7, 2016 Strauss et al.
20160287259 October 6, 2016 Hanson et al.
20160331382 November 17, 2016 Center et al.
20160374657 December 29, 2016 Kreidler
20170007262 January 12, 2017 Amplatz et al.
20170027552 February 2, 2017 Turkington et al.
20170042550 February 16, 2017 Chakraborty et al.
20170056166 March 2, 2017 Ratz et al.
20170100112 April 13, 2017 van der Burg et al.
20170119400 May 4, 2017 Amplatz et al.
20170181751 June 29, 2017 Larsen et al.
20170224354 August 10, 2017 Tischler et al.
20170340336 November 30, 2017 Osypka
20170354421 December 14, 2017 Maguire et al.
20180064446 March 8, 2018 Figulla et al.
20180070950 March 15, 2018 Zaver et al.
20180140412 May 24, 2018 Sutton et al.
20180140413 May 24, 2018 Quinn et al.
20180250014 September 6, 2018 Melanson et al.
20190133563 May 9, 2019 Glimsdale
20190175185 June 13, 2019 Amplatz et al.
20190223883 July 25, 2019 Anderson et al.
20190247053 August 15, 2019 Inouye
20190298380 October 3, 2019 Inouye
20210059685 March 4, 2021 Groff et al.
Foreign Patent Documents
1399571 February 2003 CN
202143640 February 2012 CN
104287804 January 2015 CN
104352261 February 2015 CN
106859722 June 2017 CN
109464173 March 2019 CN
10201004476 March 2012 DE
1523957 April 2005 EP
1595504 November 2005 EP
2074953 January 2009 EP
2481381 August 2012 EP
2928420 October 2015 EP
3072461 September 2016 EP
3372173 September 2018 EP
3398523 November 2018 EP
2003532457 November 2003 JP
2005324019 November 2005 JP
2007513684 May 2007 JP
2009160402 July 2009 JP
2012501793 January 2012 JP
9313712 July 1993 WO
9504132 February 1995 WO
9522359 August 1995 WO
9601591 January 1996 WO
9640356 December 1996 WO
9721402 June 1997 WO
9726939 July 1997 WO
9728749 August 1997 WO
9735522 October 1997 WO
9802100 January 1998 WO
9817187 April 1998 WO
9822026 May 1998 WO
9823322 June 1998 WO
9827868 July 1998 WO
9905977 February 1999 WO
9907289 February 1999 WO
9908607 February 1999 WO
9923976 May 1999 WO
9925252 May 1999 WO
9930640 June 1999 WO
9944510 September 1999 WO
9959479 November 1999 WO
0001308 January 2000 WO
0016705 March 2000 WO
0027292 May 2000 WO
0035352 June 2000 WO
0053120 September 2000 WO
0067669 November 2000 WO
0108743 February 2001 WO
0115629 March 2001 WO
0121247 March 2001 WO
0126726 April 2001 WO
0130266 May 2001 WO
0130267 May 2001 WO
0130268 May 2001 WO
0170119 September 2001 WO
0215793 February 2002 WO
0224106 March 2002 WO
02071977 September 2002 WO
03007825 January 2003 WO
03008030 January 2003 WO
03032818 April 2003 WO
2004012629 February 2004 WO
2007044536 April 2007 WO
2010024801 March 2010 WO
2010081033 July 2010 WO
2013060855 May 2013 WO
2013159065 October 2013 WO
2014011865 January 2014 WO
2014018907 January 2014 WO
2014089129 June 2014 WO
201406239 July 2014 WO
2015164836 October 2015 WO
2016087145 June 2016 WO
2018017935 January 2018 WO
2018187732 October 2018 WO
2019084358 May 2019 WO
Other references
  • International Search Report and Written Opinion dated Aug. 3, 2004 for International Application No. PCT/US2004/008109.
  • International Search Report and Written Opinion dated Feb. 15, 2000 for International Application No. PCT/US99/26325.
  • International Search Report dated May 20, 2003 for International Application No. PCT/US02/33808.
  • Written Opinion dated Nov. 17, 2003 for International Application No. PCT/US/02/33808.
  • International Search Report and Written Opinion dated Aug. 21, 2018 for International Application No. PCT/US2018/029684.
  • Cragg et al., “A New Percutaneous Vena Cava Filter,” American Journal of Radiology, Sep. 1983, pp. 601-604, vol. 141.
  • Cragg et al., “Nonsurgical Placement of Arterial Endoprostheses: A New Technique Using Nitinol Wire,” Radiology, Apr. 1983, pp. 261-263, vol. 147, No. 1.
  • Lock et al., “Transcatheter Closure of Atrial Septal Defects.” Circulation, May 1989, pp. 1091-1099, vol. 79, No. 5.
  • Lock et al., “Transcatheter Umbrella Closure of Congenital Heart Defects,” Circulation, Mar. 1987, pp. 593-599, vol. 75, No. 3.
  • Rashkind et al., “Nonsurgical closure of patent ductus arteriosus: clinical application of the Rashkind PDA Occluder System,” Circulation, Mar. 1987, pp. 583-592, vol. 75, No. 3.
  • Rosengart et al., “Percutaneous and Minimally Invasive Valve Procedures,” Circulation, Apr. 1, 2008, pp. 1750-1767, vol. 117.
  • Ruttenberg, “Nonsurgical Therapy of Cardiac Disorders,” Pediatric Consult, 1986, Pages not numbered, vol. 5, No. 2.
  • Sugita et al., “Nonsurgical Implantations of a Vascular Ring Prosthesis Using Thermal Shape Memory Ti/Ni Alloy (Nitinol Wire),” Trans. Am. Soc. Artif. Intern. Organs, 1986, pp. 30-34, vol. XXXII.
  • Wessel et al., “Outpatient Closure of the Patent Ductus Arteriousus,” Circulation, 1988, pp. 1068-1071, vol. 77, No. 5.
  • Tung et al., U.S. Appl. No. 61/559,941, filed Nov. 15, 2011.
  • Yue Yu et al., U.S. Appl. No. 61/557,880, filed Dec. 20, 2011.
  • Cline, “File: Fish hooks.jpg,” Wikipedia foundation , Inc., San Francisco, CA, Jun. 2007; p. 1 of 4; available online at http://en.wikipedia.org/wiki/File:Fish_hooks.jpg; last accessed Oct. 5, 2012.
  • International Search Report and Written Opinion dated Apr. 22, 2014 for International Application No. PCT/US2013/078454.
  • Aryana et al., “Incomplete Closure of the Left Atrial Appendage: Implication and Management.” Curr Cardiol Rep., 18(9):82, 2016.
  • Delurgio, “Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure with the Amplatzer Cardiac Plug.” JACC: Cardiovascular Interventions, 10(4): 400-402, 2017.
  • University of Minnesota. Atlas of Human Cardiac Anatomy, Left Atrium. Retrieved from http://www.vhlab.umn.edu/atlas/left-atrium/left-atrial-appendage/index.shtml. Accessed 2017. Downloaded 2019.
  • Saw et al., “Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak following Left Atrial Appendage Closure with the Amplatzer Cardiac Plug.” JACC: Cardiovascular Intervention. 10(4): 391-399, 2017.
  • Romero et al., “Left Atrial Appendage Closure Devices,” Clinical Medicine Insights: Cardiology, vol. 8, pp. 45-52, 2014.
  • Invitation To Pay Additional Fees And, Where Applicable, Protest Fee, mailed Oct. 13, 2016.
  • International Search Report and Written Opinion dated Oct. 14, 2019 for International Application No. PCT/US2019/047452.
  • International Search Report and Written Opinion dated Oct. 27, 2017 for International Application No. PCT/US2017/048150.
  • International Search Report and Written Opinion dated Jan. 21, 2019 for International Application No. PCT/US2018/051953.
  • International Search Report and Written Opinion dated Oct. 13, 2016 for International Application No. PCT/US2016/043363.
  • International Search Report and Written Opinion dated Mar. 17, 2020, for International Application No. PCT/US2019/065243.
  • International Search Report and Written Opinion dated Sep. 9, 2019 for International Application No. PCT/US2019/033698.
  • Blackshear et al; “Appendage Obliteration to Reduce Stroke in Cardiac Surgical Patients with Atrial Fibrillation”, Ann. Thoracic Surgery, pp. 755-759, 1996.
  • Lindsay, “Obliteration of the Left Atrial Appendage: A Concept Worth Testing”, Ann. Thoracic Surgery, 1996.
  • Invitation To Pay Additional Fees dated Feb. 22, 2019 for International Application No. PCT/US2018/066163.
  • International Search Report and Written Opinion dated Oct. 20, 2020 for International Application No. PCT/US2020/042192.
  • International Search Report and Written Opinion dated Oct. 23, 2020 for International Application No. PCT/US2020/048437.
  • Watchman FLX™ Left Atrial Appendage Closure Device, Boston Scientific. 5 pages, 2022.
  • International Search Report and Written Opinion dated Oct. 25, 2022 for International Application No. PCT/US2022/036092.
Patent History
Patent number: 12653539
Type: Grant
Filed: Oct 20, 2023
Date of Patent: Jun 16, 2026
Patent Publication Number: 20240041469
Assignee: Boston Scientific Scimed, Inc. (Maple Grove, MN)
Inventors: Jan-Hung Chen (St. Paul, MN), Harishankar Natesan (Shoreview, MN), Thyna M. Chau (Woodbury, MN)
Primary Examiner: Shaun L David
Assistant Examiner: Rachael L Geiger
Application Number: 18/490,986
Classifications
Current U.S. Class: With Emboli Trap Or Filter (606/200)
International Classification: A61B 17/12 (20060101);